MAUDE Adverse Event Report: COLOPLAST A/S FOLYSIL CATHETER; CATHETER, RETENTION TYPE, BALLOON

Model Number AA61181002

Device Problem Burst Container or Vessel (1074)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Manufacturer Narrative

No product was received for evaluation, however, balloon burst issue is known and is monitored on a monthly basis.Possible root cause is an area of weakness in the silicone material of the balloon.

Event Description

According to the available information, the balloon burst when changing the catheter.There was no harm to the user.

• Brand Name: FOLYSIL CATHETER
• Type of Device: CATHETER, RETENTION TYPE, BALLOON
• Manufacturer (Section D): COLOPLAST A/S; holtedam 1; humlebæk 3050 ; DA 3050
• Manufacturer (Section G): COLOPLAST A/S MANUFACTURING; 9 avenue edmond rostand; sarlat-la-caneda 24206 ; FR 24206
• Manufacturer Contact: usauv autumn valentine ; 1601 west river road north; minneapolis, MN 55411 ; 8007880293
• MDR Report Key: 11132104
• MDR Text Key: 225534535
• Report Number: 9610711-2021-00009
• Device Sequence Number: 1
• Product Code: EZL
• UDI-Device Identifier: 03600040127605
• UDI-Public: 03600040127605
• Combination Product (y/n): N
• PMA/PMN Number: K013174
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other
• Type of Report: Initial
• Report Date: 01/07/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/07/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: AA61181002
• Device Catalogue Number: AA6118
• Device Lot Number: 7314798
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/06/2020
• Date Device Manufactured: 02/25/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1